On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011

FDA DeterminedCause 2

PREMARKET APPROVAL: No Marketing Application

Action

Nanotherapeutics sent an Urgent: Medical Device Recall letter dated April 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove any unimplanted/unsold product shipped to them. Customers were asked to notify their customers and instruct them to make notification until the end user (hospital/physician) is reached.
Recall Instructions:
Immediately examine inventory and quarantine product subject to recall.
Return all quarantined product subject to recall to:
Nanotherapeutics, Inc.
Attn: Receiving Department
13859 Progress Blvd, Suite 300
Alachua, Florida 32615
For questions call 386-462-9663.